TFN-ADVANCE 04.037.161SRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10886982096692), received between Mar 22, 2018 and May 14, 2025 — classified as 12 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (9 reports).

9 other recalls cover devices cleared under the same FDA submission (K131548, K160167); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE TFNA LAG SCREW STILL SLID ALLOWING THE FEMORAL NECK TO COLLAPSE AFTER THE TORQUE LIMITER WAS USED TO STATICALLY LOCK THE SCREW IN PLACE TO PREVENT THE SLIDE. THE PATIENT EXPERIENCED ADVERSE CONSEQUENCES. THE FRACTURE SHIFTED ITS POSITION. THERE ARE NO REVISION PLANS SCHEDULED.

  Patient problems: Malunion of Bone

  MAUDE report 22022455 ↗
• MalfunctionApr 17, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE TFNA LAG SCREW MISSED THE NAIL AND WENT ANTERIOR OUTSIDE THE NAIL. THE INCIDENT WAS NOT IDENTIFIED TILL (B)(6) 2025. THIS WAS NOT OBSERVED DURING THE FINAL X-RAYS. THE PATIENT STATUS/OUTCOME / CONSEQUENCES ARE UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 21856183 ↗
• InjuryFeb 16, 2023Break; Break

  THE NAIL BROKE INTO TWO PIECES. BOTH PIECES WERE REMOVED. THERE WERE NO ALLEGATIONS AGAINST THE SCREWS.

  Patient problems: Failure of Implant

  MAUDE report 16387028 ↗
• InjuryOct 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY OCCURRED ON (B)6) 2022 DUE TO FEMUR NONUNION AND MAL-REDUCTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 11MM/130 DEG TI CANN TFNA 400MM/LEFT - STERILE. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 15699885 ↗
• InjuryFeb 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6), 2022, THE PATIENT UNDERWENT A TROCHANTERIC FIXATION NAIL-ADVANCED (TFNA) REMOVAL PROCEDURE FOR AN UNKNOWN REASON. IT WAS NOTED THAT INITIAL IMPLANTATION WAS DONE ON (B)(6), 2021. PATIENT AND PROCEDURE OUTCOME IS UNKNOWN. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) 11MM/130 DEG TI CANN TFNA 400MM/LEFT - STERILE. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13552631 ↗
• InjuryJul 21, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT SURGERY WITH THE TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) SYSTEM. THE IMPLANTS BROKE IN THE PATIENTS A FEW WEEKS LATER ON AN UNKNOWN DATE. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT REVISION SURGERY. THE TFNA IMPLANTS WERE REMOVED AND A LARGER NAIL WAS IMPLANTED. THE PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. THERE IS NO FURTHER INFORMATION AVAILABLE. CONCOMITANT DEVICE REPORTED: UNK - SCREW: (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN) . HELICAL BLADE (PART# 04.038.390S; LOT# UNKNOWN; QUANTITY: 1). THIS REPORT IS FOR ONE (1) 11MM/130 DEG TI CANN TFNA 400MM/LEFT - STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12204780 ↗
• InjuryJun 2, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE IMPLANT 11MM/130 DEG TITANIUM CANN TFNA 400MM/LEFT - STERILE BROKE AT THE BLADE INTERFACE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY REPORTED. THE PROCEDURE AND PATIENT OUTCOMES WERE UNKNOWN. CONCOMITANT DEVICES REPORTED: UNKNOWN NAIL HEAD ELEMENTS: TFNA HELICAL BLADE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS COMPLAINT INVOLVES 1 DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 10112141 ↗
• InjuryApr 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT REMOVAL OF A PROXIMAL FEMORAL NAILING SYSTEM (TFNA) TO CONVERT TO A TOTAL HIP ARTHROPLASTY DUE TO POST-TRAUMATIC ARTHRITIS. THE PATIENT'S STATUS IS UNKNOWN. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Arthritis

  MAUDE report 9929423 ↗
• InjuryOct 30, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REVISION SURGERY DUE TO A BROKEN TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) NAIL. INITIALLY, THE PATIENT HAD THE ORIGINAL SURGERY AT AN OUTSIDE HOSPITAL. THE ISSUE WAS DISCOVERED WHEN THE PATIENT PRESENTED WITH VARUS DEFORMITY. DURING THE REVISION SURGERY, ALL ORIGINAL IMPLANTS WERE SUCCESSFULLY REMOVED AND THE PATIENT WAS REVISED TO A 4.5 LCP PROXIMAL FEMUR HOOK PLATE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY SURGICAL DELAY. PATIENT STATUS WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: TFNA HELICAL BLADE (PART # 04.038.390S, LOT # H758983, QUANTITY 1), UNKNOWN LOCKING SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9255156 ↗
• MalfunctionSep 4, 2019Use of Device Problem; Use of Device Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, WHEN PERFORMING TFNA NAIL SURGERY THE SURGEON MADE A TAC MEASUREMENT AND WANTED TO REPLACE A 415 NAIL WITH A NAIL OF LENGTH 400. HE STARTED SURGERY AND A NAIL 11 WAS USED WHICH, UPON IMPACT, THEY REALIZED IT WAS TOO LONG. THEY DECIDED TO CUT THE DISTAL END AND REINSERT IT AGAIN. THE SURGERY WAS FINISHED WITHOUT ANY OTHER CONSEQUENCE AND THE SURGEON WAS SATISFIED WITH THE RESULT. THIS REPORT IS FOR ONE (1) 11 MM/130 DEG TI CANN TFNA 400 MM/LEFT - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8961402 ↗
• InjuryJul 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS 2 OF 4 FOR (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 8819525 ↗
• MalfunctionApr 11, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, THE SURGEON REMOVED THE RETAINED BROKEN TROCHANTERIC FEMORAL NAIL ADVANCED (TFNA) NAIL USING THE NAIL EXTRACTOR BUT WAS NOT ABLE TO BE REMOVED INTRAOPERATIVELY, AND WAS IMMEDIATELY DISCARDED BECAUSE THE BROKEN NAIL WAS DANGEROUSLY SHARP. ALL IMPLANTS WERE SAFELY EXTRACTED. SURGEON WAS ALSO DIRECTLY REDUCING THE FRACTURE WITH A CABLE, HARVESTING BONE FROM THE FEMUR WITH RADIOIMMUNOASSAY (RIA), AND GRAFTING NON-UNION SITE WITH AUTOGRAFT AND ALLOGRAFT (VIVIGEN FORMABLE 5CC), AND FENESTRATED TROCHANTERIC FEMORAL NAIL ADVANCED (TFNA) SCREW, AND TRAUMACEM WAS ALSO USED TO AUGMENT THE FIXATION IN THE FEMORAL HEAD. PATIENT HAD A REVERSE INTERTROCHANTERIC HIP FRACTURE OF LEFT HIP LAST FALL OF 2018. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE OUTCOME IS UNKNOWN BUT WITH A PATIENT CONSEQUENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8506028 ↗
• InjuryApr 8, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REVISION SURGERY OF A FEMUR FRACTURE DUE TO NONUNION, UPPER THIGH PAIN, DELAYED HEALING, AND SUBSEQUENT BREAKING OF ONE (1) TITANIUM LOCKING SCREW W/T25 STARDRIVE 2MM FOR INTRAMEDULLARY NAILS (IM). THE SCREW WAS ONE OF TWO DISTAL INTERLOCKING SCREWS, BUT THIS WAS THE ONLY SCREW THAT WAS BROKEN. THE PROXIMAL SEGMENT OF THE TROCHANTERIC FEMORAL NAIL ADVANCE (TFNA) NAIL WAS BROKEN ABOVE THE HELICAL BLADE/SCREW JUNCTION. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICES: TFNA HELICAL BLADE (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1), TITANIUM LOCKING SCREW W/T25 STARDRIVE 2MM FOR IM (PART: 04.005.532, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A TITANIUM (TI) CANNULATED TFNA NAIL. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Impaired Healing; No Code Available; Pain

  MAUDE report 8492504 ↗
• InjuryOct 31, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2018 DUE TO NON-UNION AND BROKEN HARDWARE. THE TROCHANTERIC FEMORAL NAIL-ADVANCE (TFNA) NAIL WAS BROKEN AT THE ENTRY POINT OF THE HELICAL BLADE; THE TWO (2) TFNA LOCKING SCREWS AT THE END OF THE NAIL WERE ALSO BROKEN. ALL THE IMPLANTS WERE REMOVED EXCEPT FOR HALF OF A LOCKING SCREW. PATIENT WAS REVISED WITH ANOTHER TFN, HELICAL BLADE AND TWO (2) LOCKING SCREWS. THE SURGEON ALSO IMPLANTED ANTIBIOTICS, CALCIUM SULFATE, AND BONE GRAFT MATERIAL. PROCEDURE OUTCOME AND PATIENT STATUS IS UNKNOWN. THE PATIENT WAS ORIGINALLY TREATED BY A DIFFERENT SURGEON ON (B)(6) 2016 FOR A COMMINUTED SUBTROCHANTERIC FRACTURE ON THE LEFT LEG USING A TFNA HELICAL BLADE, NAIL, TWO (2) 5.0 LOCKING SCREWS, AS WELL AS A CABLE WITH CRIMP. THE REVISION SURGEON SAID THAT THE NAIL BREAKAGE WAS DUE TO THE TECHNIQUE OF THE PREVIOUS SURGEON PUTTING A CABLE ABOVE THE LESSER TROCHANTER, CUTTING OFF BLOOD SUPPLY AND NOT ALLOWING THE BONE TO HEAL. CONCOMITANT DEVICES: TFNA 90MM HELICAL BLADE (PART: 04.038.290, LOT: UNKNOWN, QUANTITY: 1); 1.7MM CABLE WITH CRIMP 750MM (PART: 298.801.01S, LOT: UNKNOWN, QUANTITY: 4). THIS REPORT IS FOR AN TITANIUM (TI) CAN

  Patient problems: No Code Available

  MAUDE report 8025388 ↗
• InjurySep 20, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANTATION PROCEDURE ON (B)(6) 2018 FOR A BROKEN PROXIMAL FEMORAL NAILING SYSTEM (TFNA). THE SURGEON SENT X-RAYS OF THE PATIENT TO THE SALES CONSULTANT AND ASKED THEM TO BRING EQUIPMENT FOR THE CASE. ON AN UNKNOWN DATE, FOLLOWING IMPLANTATION, THE PATIENT HAD FALLEN, AND THE NAIL BROKE AT THE PROXIMAL BOLT IN THE DISTAL PART OF THE NAIL. THE NAIL WAS THE ONLY BROKEN DEVICE; THERE WAS NO MALFUNCTION OF THE HELICAL BLADE OR DISTAL LOCKING SCREW. ALL IMPLANTS WERE REMOVED. THE FEMUR WAS THEN PLATED IN THE LATERAL POSITION WITH A SYNTHES VARIABLE ANGLE (VA) CONDYLAR PLATE AND AN ANTERIOR 1/3 TUBULAR PLATE. IT WAS ALSO NAILED WITH A NON-SYNTHES CEPHALOMEDULLARY NAIL (CM) NAIL. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICES: DISTAL LOCKING SCREW (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY 1); TFNA HELICAL BLADE 85MM (PART: 04.038.285, LOT: H384825, QUANTITY 1). THIS REPORT IS FOR A 11MM/130 DEGREE TITANIUM (TI) CANNULATED TFNA 400MM/LEFT ¿ STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7893459 ↗
• MalfunctionAug 17, 2018Break; Break

  IT WAS REPORTED THAT UPON OPENING THE SET DURING A TROCHANTERIC FIXATION NAIL ADVANCE (TFNA) REMOVAL ON (B)(6) 2018, THE TIP OF THE HELICAL BLADE/SCREW EXTRACTOR WAS DISCOVERED TO BE BROKEN OFF AND COULD NOT BE USED TO REMOVE THE (TFNA) SCREW. THE INSERTION HANDLE WAS THEN CONNECTED WITH THE HELICAL BLADE/SCREW COUPLING SCREW TO THE (TFNA) SCREW IN AN ATTEMPT TO REMOVE THE (TFNA) SCREW. THE SCREW WAS FINALLY REMOVED, BUT THE SCREW INSERTER, COUPLING SCREW, AND (TFNA) SCREW WERE ALL DAMAGED IN THE PROCESS. THE HELICAL BLADE/SCREW COUPLING SCREW WON'T SLIDE IN, THE SCREW INSERTER WAS BENT AND THE TFNA SCREW PEELED OFF. IT WAS UNKNOWN WHEN THE HARDWARE WAS IMPLANTED. THE HARDWARE REMOVAL WAS SCHEDULED DUE TO THE PATIENT'S AGE. THERE WAS A 15 MINUTE SURGICAL DELAY. THE SURGERY WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICES REPORT: INSERTION HANDLE (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1) THIS REPORT IS FOR ONE (1) 11MM 130 DEGREE CANNULATED TFNA NAIL 400MM LEFT THIS IS REPORT 5 OF 5 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7794309 ↗
• InjuryMay 22, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT HAD A REVISION SURGERY DUE TO BONE FRACTURE ON (B)(6) 2018. THE TROCHANTERIC FIXATION NAIL-ADVANCE (TFNA) WAS BROKEN PRIOR TO EXTRACTION. THE PATIENT WAS ORIGINALLY TREATED WITH PROPHYLACTIC NAILING FOR METASTATIC CANCER. LESION WAS DETECTED BY COMO TOPOGRAPHY (CT) SCAN TO TRY TO PREVENT A FRACTURE. THE NAIL BROKE AT THE NAIL AND HELICAL BLADE INTERFACE. THE PROXIMAL END OF THE NAIL BROKE COMPLETELY AWAY FROM THE DISTAL END. THERE WERE NO ISSUES WITH THE HELICAL BLADE OR LOCKING SCREW. BOTH DEVICES WERE INTACT. THERE WERE NO BONY FRAGMENTS GENERATED DURING EXTRACTION OR REVISION. ALL HARDWARE WAS EASILY REMOVED. THERE WAS NO SURGICAL DELAY. ROUTINE INTRAOPERATIVELY X-RAYS WERE TAKEN STANDARD FOR THE PROCEDURE. PATIENT WAS REVISED TO A STANDARD TROCHANTERIC FIXATION NAIL (TFN) ¿ HELICAL BLADE AND NAIL. CONCOMITANT DEVICES REPORTED: TFNA HELICAL BLADE 110 MM STERILE (PART 04.038.310S, LOT H271336, QUANTITY 1); 5.0 MM DISTAL LOCKING SCREW (PART/LOT UNKNOWN, QUANTITY 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture

  MAUDE report 7533058 ↗
• MalfunctionMar 22, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING ORIGINAL PROCEDURE OF ORIF LEFT HIP ON (B)(6) 2018, SURGEON WAS TRYING TO CONNECT THE NAIL TO INSERTION HANDLE AND HE CROSS THREADED CONNECTING SCREW INTO NAIL WHICH CAUSED NAIL NOT TO CONNECT PROPERLY TO INSERTION HANDLE. THE 3.2 MM GUIDE WIRE WAS SITTING TOO LOW OR TOO HIGH IN THE NAIL. UPON USING 6/9 STEPPED DRILL BIT, THE DRILL BIT TIP HIT INSIDE OF THE NAIL CAUSING TIP OF THE DRILL BIT TO BREAK OFF INTO THE PATIENT INTO MULTIPLE PIECES. FRAGMENTS WERE EMBEDDED IN PATIENT. SURGEON DID NOT ATTEMPTED TO RETRIEVE THE FRAGMENTS. UPON OF INSERTION OF HELICAL BLADE, THE GUIDE WIRE ADVANCED THROUGH THE FEMORAL HEAD. DUE TO THIS OCCURRING, THE SURGEON TOOK OUT THE HELICAL BLADE, TOOK OUT THE GUIDE WIRE AND RE INSERTED THE HELICAL BLADE WITHOUT A GUIDE WIRE. THERE WAS 2 MIN DELAY IN PROCEDURE. PROCEDURE WAS COMPLETED SUCCESSFULLY AND PATIENT WAS REPORTED AS STABLE. CONCOMITANT DEVICES REPORTED: INSERTION HANDLE (PART # - 03.037.012, LOT # UNKNOWN, QTY ¿ 1), HELICAL BLADE (PART # 04.038.310S, LOT # H379767, QTY ¿ 1). THIS COMPLAINT INVOLVES FOUR DEVICES (CONNECTING SCREW, NAIL, DRILL BIT, GUIDE WIRE). THIS REPORT IS 4 OF 4 FOR (B)(4).

  Patient problems: Not Applicable

  MAUDE report 7364594 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K131548, K160167. One submission often covers many models, so check the product and lot details in each record.

• Z-1240-2024 · Jan 24, 2024 · Open, Classified
  TFNA Femoral Nail 11mm, right, 130, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.144S
• Z-1239-2024 · Jan 24, 2024 · Open, Classified
  TFNA Femoral Nail 9mm, right, 130, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.944S
• Z-1246-2023 · Feb 1, 2023 · Open, Classified
  TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 200MM STERILE. Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.213S
• Z-1248-2023 · Feb 1, 2023 · Open, Classified
  TFN-Advanced Femoral Nail 12MM/130 DEG TI CANN TFNA 170MM STERILE. Intended for temporary fixation and stabilization of proximal femur fractures Part Number: 04.037.242S
• Z-1247-2023 · Feb 1, 2023 · Open, Classified
  TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 170MM - STERILE. Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.212S
• Z-0126-2016 · Sep 21, 2015 · Terminated
  Synthes Screw Inserter; for use with Intramedullary Rod, orthopedic device. Used to secure the head element to the head element inserter to prevent disengagement during head eleme
• Z-2091-2015 · Jun 10, 2015 · Terminated
  Helical Blade Inserter for Trochanteric Fixation Nail-ADVANCED (TFNA); intended to secure the head element to the head element inserter to prevent disengagement during head element
• Z-1600-2015 · Apr 9, 2015 · Terminated
  TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
• Z-1352-2015 · Feb 24, 2015 · Terminated
  Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aiming Arm and 125 Degree Aiming Arm are a part of the TFN-ADVANCED (TFNA) System. The TFN-ADVANCED Proxima